FDA Recalls Two Supplements with Undeclared Sildenafil

The U.S. Food and Drug Administration announced two separate voluntary recalls this month for over-the-counter sexual enhancement supplements that contain undeclared prescription drug ingredients, posing potential health risks to consumers. The products, marketed as natural herbal aids, include sildenafil, the active component in Viagra, and in one case tadalafil, found in Cialis, neither of which is approved for unsupervised use.

In the first recall, Primal Supplements Group LLC, based in New Mexico, initiated a voluntary withdrawal of its Primal Herbs "Volume" product after laboratory testing confirmed the presence of undeclared sildenafil. The affected units were sold online through the company's website between July 2 and September 19, 2025, and come in 8.5-ounce round containers with green labels. The supplement, promoted to support men's performance and drive with ingredients such as maca, American ginseng, Siberian ginseng, ginkgo biloba, and ginger, did not list sildenafil on its label.

The FDA issued a public notice on the recall earlier this week, emphasizing that sildenafil is a prescription medication intended for treating erectile dysfunction under medical...